Isotretinoin is a retinoid sold in the U.S. under 4 brand and generic names, for acne vulgaris, leukemia and neuroblastoma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Absorica (application NDA021951). Other isotretinoin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Recommended dosage for: Isotretinoin capsules is 0.5 to 1 mg/kg/day given in two divided doses without regard to meals for 15 to 20 weeks (2.1) Adult patients with very severe disease (scarring, trunk involvement) may increase dosage to 2 mg/kg/day of isotretinoin capsules in divided doses. (2.1) Once daily dosing is not recommended. (2.1) If a dose of isotretinoin capsules is missed, just skip that dose. Do not take two doses of isotretinoin capsules at the same time. (2.1) Perform pregnancy tests prior to prescribing, each month during therapy, end of therapy, and one month after discontinuation. (2.3 , 8.3) Prior to prescribing, perform fasting lipid profile and liver function tests. (2.3) 2.1 Recommended Dosage The recommended dosage of: Isotretinoin capsules is 0.5 to 1 mg/kg/day given in two divided doses with or without meals for 15 to 20 weeks (see Table 1). To decrease the risk of esophageal irritation, instruct patients to swallow the capsules with a full glass of liquid. During treatment, the dosage may be adjusted according to response of the disease and/or adverse reactions, some of which may be dose-related. Adult patients whose disease is very severe with scarring or is primarily manifested on the trunk may require dosage adjustments up to 2 mg/kg/day for isotretinoin capsules in divided doses, as tolerated. The safety and effectiveness of once daily dosing with…
The following adverse reactions with isotretinoin capsules or other isotretinoin capsule products are described in more detail in other sections of the labeling: Embryo-Fetal Toxicity [see Warnings and Precautions ( 5.1 )] Psychiatric Disorders [see Warnings and Precautions ( 5.4 )] Intracranial Hypertension (Pseudotumor Cerebri) [see Warnings and Precautions ( 5.5 )] Serious Skin Reactions [see Warnings and Precautions ( 5.6 )] Pancreatitis [see Warnings and Precautions ( 5.7 )] Lipid Abnormalities [see Warnings and Precautions ( 5.8 )] Hearing Impairment [see Warnings and Precautions ( 5.9 )] Hepatotoxicity [see Warnings and Precautions ( 5.10 )] Inflammatory Bowel Disease [see Warnings and Precautions ( 5.11 )] Musculoskeletal Abnormalities [see Warnings and Precautions ( 5.12 )] Ocular Abnormalities [see Warnings and Precautions ( 5.13 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.14 )] The following adverse reactions associated with the use of isotretinoin capsules were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Dose Relationship Cheilitis and hypertriglyceridemia were dose related. Body as a Whole Fatigue, irritability, pain,…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Capsule | Generic | $155 | View → | |
| 2 |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| R135 | 10 mg | blue | oval | — |
| R136 | 20 mg | pink | oval | — |
| RI | 30 mg | red | oval | — |
| R137 | 40 mg | green | oval | — |
| 570 | 10 mg | yellow | oval | — |
| 571 | 20 mg | pink |
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Claravis (isotretinoin capsule
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Teva Pharmaceuticals USA, Inc · Apr 6, 2026
Amnesteem (Isotretinoin) Capsules
Failed Dissolution Specifications
MYLAN PHARMACEUTICALS INC · Feb 24, 2026
Isotretinoin Capsules
Superpotent and Subpotent
Teva Pharmaceuticals USA, Inc · Jan 12, 2026
Isotretinoin Capsules
Superpotent and Subpotent
Teva Pharmaceuticals USA, Inc · Jan 12, 2026
Isotretinoin Capsules
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Teva Pharmaceuticals USA, Inc · Mar 28, 2024
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Pregnancy ( 4.1 , 8.1 ) Hypersensitivity to this product or any of its components ( 4.2 , 5.14 ) 4.1 Pregnancy Isotretinoin capsules are contraindicated in pregnancy [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. 4.2 Hypersensitivity Isotretinoin capsules are contraindicated in patients with hypersensitivity to isotretinoin (or Vitamin A, given the chemical similarity to isotretinoin) or to any of its components (anaphylaxis and other allergic reactions have occurred) [see Warnings and Precautions (5.14) ] .
Vitamin A: may cause additive adverse reactions (7.1) Tetracyclines: avoid concomitant use (7.2) 7.1 Vitamin A Isotretinoin capsules are closely related to vitamin A. Therefore, the use of both vitamin A and isotretinoin capsules at the same time may lead to vitamin A related adverse reactions. Patients treated with isotretinoin capsules should be advised against taking supplements containing Vitamin A to avoid additive toxic effects. 7.2 Tetracyclines Concomitant treatment with isotretinoin capsules and tetracyclines should be avoided because isotretinoin use has been associated with a number of cases of intracranial hypertension (pseudotumor cerebri), some of which involved concomitant use of tetracyclines [see Warnings and Precautions (5.5) ] . 7.3 Phenytoin Phenytoin is known to cause osteomalacia. No formal clinical trials have been conducted to assess if there is an interactive effect on bone loss between phenytoin and isotretinoin. Therefore, caution should be exercised when using these drugs together. 7.4 Systemic Corticosteroids Systemic corticosteroids are known to cause osteoporosis. No formal clinical trials have been conducted to assess if there is an interactive effect on bone loss with concomitant use of systemic corticosteroids and isotretinoin. Therefore, caution should be exercised when using these drugs together. 7.5 Norethindrone and Ethinyl Estradiol In a…
| Not yet rated |
| Prescription |
| Capsule |
| Generic |
| $155 |
| View → |
| 3 | Not yet rated | Prescription | Capsule | Generic | $155 | View → |
| 4 | Not yet rated | Prescription | Capsule | Generic | $155 | View → |
| oval |
| — |
| 573 | 30 mg | brown | oval | — |
|---|
| V10 | 10 mg | yellow | capsule | — |
|---|
| V20 | 20 mg | pink | capsule | — |
|---|
| V30 | 30 mg | pink | capsule | — |
|---|
| V40 | 40 mg | orange | capsule | — |
|---|
| J1 | 10 mg | blue | oval | — |
|---|